Objective To develop a preliminary "pulmonary nodule symptom scale" based on the Delphi method, providing a tailored, standardized, normalized, and promotable symptomatic evaluation tool for the efficacy assessment of pulmonary nodule patients treated with traditional Chinese medicine or integrated traditional Chinese and Western medicine interventions. Methods A preliminary pool of scale items was formed through literature review, interviews with doctors and patients, and reference to guidelines and consensus on pulmonary nodules and patient-reported outcome (PRO) scales related to lung cancer. Two rounds of expert consultation were conducted using the Delphi method. Based on the concentration and variation indicators of expert evaluations, and considering experts’ suggestions for specific item deletions and modifications, a core group meeting was held to screen and refine the scale items. Results Invitations were sent to 54 experts, with 51 accepting the consultation. The active coefficient for the first round of consultation was 94.4%, and for the second round, it was 100%. The average authority coefficient for the 51 experts was 0.896. The Kendall’s coefficient of concordance and the average coefficient of variation for the first and second rounds of consultation were 0.215 (P<0.001) and (0.34±0.07), 0.162 (P<0.001) and (0.24±0.05), respectively. Through two rounds of Delphi expert consultation, a preliminary "pulmonary nodule symptom scale" covering 17 items across four dimensions - respiratory symptoms, systemic manifestations, psychological state, and overall assessment - was formed. Conclusion The experts participating in this Delphi consultation had high authority and enthusiasm, and they have a good level of acceptance and consistency for the preliminary "pulmonary nodule symptom scale". Subsequent empirical research will be conducted on a large sample cohort of pulmonary nodule patients to verify the scale’s stability and effectiveness.
ObjectiveTo conduct item analysis on the Pulmonary Nodule Symptom Scale preliminarily developed through Delphi consultation, establish the final version of the scale, and evaluate its reliability and validity. MethodsPatients with pulmonary nodules who visited the outpatient department of the First Affiliated Hospital of Guangzhou University of Chinese Medicine from May to October 2024 were enrolled according to diagnostic criteria for pulmonary nodules and predefined inclusion/exclusion standards. Demographic data, medical history, and imaging characteristics of pulmonary nodules were collected, and participants completed the preliminary Pulmonary Nodule Symptom Scale developed through Delphi consultation. Four item analysis methods, including discrete trend method, critical ration method, correlation coefficient method, and Cronbach’s α coefficient, were employed for final item screening to determine the definitive version of the scale. Reliability and validity were systematically assessed via Cronbach’s α, split-half reliability, content validity, and construct validity. ResultsA total of 153 patients with pulmonary nodules were included, comprising 56 (36.60%) males and 97 (63.40%) females, with a mean age of (53.77±12.61) years. The median disease duration was 6 (1, 20) months, and mean nodule diameter was (7.64±4.37) mm, including 38 (24.84%) solitary patients and 115 (75.16%) multiple patients, as well as 39 (25.49%) solid nodules and 114 (74.51%) ground-glass nodules. Based on comprehensive results from four item analysis methods and core group discussion, two items ("symptom severity" and "quality of life") in the overall evaluation dimension were removed. The final scale comprised 15 items across three dimensions: respiratory symptoms, systemic manifestations, and psychological state. The Cronbach’s α coefficient was 0.84, with a Spearman-Brown coefficient of 0.912. Item-level content validity indices ranged from 0.824 to 1.000, while the scale-level content validity index reached 0.933. Kaiser-Meyer-Olkin (KMO) measure was 0.803, with Bartlett’s test of sphericity showing statistical significance (P<0.001). Exploratory factor analysis extracted three factors explaining 52.48% of total variance, and the rotated component matrix distribution generally aligned with the predefined three dimensions. ConclusionThe definitive version of the Pulmonary Nodule Symptom Scale contains 15 items across three dimensions (respiratory symptoms, systemic manifestations, and psychological state). Reliability and validity evaluations demonstrate good reliability and satisfactory validity for the scale.
ObjectiveTo systematically evaluate the efficacy and safety of traditional Chinese medicine (TCM) compound in treating pulmonary nodules, providing basic evidence-based medical evidence for TCM intervention in pulmonary nodules. MethodsComputer search of PubMed, CNKI, Wanfang, VIP, and SinoMed was conducted to select randomized controlled trials (RCTs) of TCM compound intervention in pulmonary nodules, with the retrieval time from the inception to November 29, 2023. The Cochrane bias risk assessment tool was used to evaluate the quality of the included studies, and Review Manager 5.4 was used for Meta-analysis. ResultsA total of 18 RCTs were included, covering 8 provinces across the country, with a total sample size of 1301 patients. The TCM compounds used in the included studies all incorporated the method of dissolving phlegm and dissipating nodules. There was a high risk of bias uncertainty in the included studies. Meta-analysis results suggested that TCM compound could significantly reduce the diameter of pulmonary nodules [MD=?1.41, 95%CI (?1.70, ?1.13), P<0.001], decrease the number of nodules [MD=?0.37, 95%CI (?0.73, ?0.01), P=0.05], alleviate clinical symptoms [MD=?4.84, 95%CI (?6.04, ?3.64), P<0.001], and improve lung function [forced expiratory volume in one second (FEV1), MD=0.55, 95%CI (0.09, 1.01), P=0.02; FEV1/forced vital capacity, MD=6.12, 95%CI (4.47, 7.78), P<0.001]. However, there was no statistically significant difference in the probability of malignancy between the experimental group and the control group [MD=?0.01, 95%CI (?0.01, 0.00), P=0.09]. ConclusionTCM compound can significantly reduce the diameter of pulmonary nodules, decrease the number of nodules, alleviate clinical symptoms, and improve lung function, but future multicenter, large-sample, high-quality RCTs are still needed to further explore and verify this conclusion.
